Policy & Regulation
TVAX Biomedical wins FDA fast track designation for potential glioblastoma multiforme treatment
5 June 2020 -

Clinical development company TVAX Biomedical revealed on Thursday that it has received the US Food and Drug Administration's (FDA) fast track designation to accelerate the marketing approval of its vaccine-enhanced adoptive T cell therapy (VACT) for the treatment of glioblastoma multiforme (GBM), a deadly form of brain cancer.

The company has completed Phase 1 and 2a studies in GBM. Significant benefit was demonstrated in GBM patients using TVAX's patented VACT in those studies.

Planned studies will evaluate VACT in newly diagnosed GBM patients who have healthy immune systems and minimal disease at a time when VACT would be anticipated to generate maximal efficacy.

TVAX is seeking investors and corporate alliances to support the development of its lead candidate.

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